APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

Active ingredient:

ramipril, Quantity: 1.25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: lactose monohydrate; iron oxide yellow; Gelatin; magnesium stearate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? Treatment of hypertension. (Data are currently not available to support the use of ramipril in renovascular hypertension).,? Post MI heart failure.,? Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day.,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease.,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L; HDL cholesterol < 0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Product summary:

Visual Identification: yellow cap & white body imprinted with APO 1.25 in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-09-27